Compositions

Abstract

The present invention involves the novel use of H 2 and H 3 agonists, as erectogenic agents in the treatment of male and female sexual dysfunction in an animal, including humans. The H 2 and H 3 agonists may be administered by intracavernousm injection, topically, transdermally, or intraurethrally. The method of use may also include a second therapeutic agent which either facilitates, potentiates or is erectogenic. The second agent may be administered sequentially or contemporaneously with either the H 2 or H 3 agonist.

What is claimed is: 
     
       1. A method of treating sexual dysfunction in an animal in need thereof which comprises administering to said animal an effective amount of an H 2  agonist. 
     
     
       2. The method according to claim 1 wherein the H 2  agonist is a compound of the formula   Het-CH.sub.2 SCH.sub.2 CH.sub.2 NH--C(═NH)--NH(CH.sub.2).sub.3 -Het'(I)     wherein   Het is a 4-imiazolyl, 5-methyl-4-imidazolyl, 5-ethyl-4-imidazolyl, 5-halogeno-4-imidazolyl, 2-thiazolyl, 3-isothiazolyl, 4-halogen-3-isothiazolyl, 2-pyridyl, 3-methyl-4-pyridyl, 3-ethyl-2-pyridyl, 3-halogeno-2-pyridyl, 3-hydroxy-2-pyridyl, 3-methoxy-4-pyridyl or 3-ethoxy-2-pyridyl ring;   Het' is a 4-imidazole ring;   halogeno is bromo or chloro; or a hydrate or pharmaceutically acceptable salt or hydrated salt thereof.   
     
     
       3. The method according to claim 2 which is N- 3-(4-Imidazolyl)propyl!-N'- 2-(4-methyl-5-imidazolylmethyl-thio)ethyl!guanidine or a hydrate of pharmaceutically acceptable salt thereof. 
     
     
       4. The method according to claim 1 wherein the H 2  agonist is of the formula: ##STR15## wherein R 1  and R 2  may be the same or different and are methyl or ethyl, or the pharmaceutically acceptable salts thereof. 
     
     
       5. The method according to claim 4 wherein the compound is (3-dimethylaminopropyl)isothiourea and pharmaceutically acceptable salts thereof. 
     
     
       6. The method according to claim 1 whereby the method of treatment is by intracavernous injection, topical, transdermal, or intraurethral administration of the H 2  agonist. 
     
     
       7. The method according to claim 1 which further comprises administering the H 2  agonist with a second therapeutic agent which either facilitates, potentiates or is erectogenic. 
     
     
       8. The method according to claim 7 wherein the H 2  agonist is further administered in combination with one or more therapeutically active agents which are an H 3  agonist, histamine, an α-adrenergic blocker, a dopamine D 2  -antagonist, nitric oxide releaser, prostaglandin or an analog thereof having a vasoactive function, calcium antagonist, CGRP, VIP, phentolamine, physiostigmine, neostigmine, hydralazine, sodium nitroprusside, phenoxybenzamine, or an H 1  antagonist. 
     
     
       9. The method according to claim 8 wherein the second agent is administered sequentially or contemporaneously with the H 2  agonist. 
     
     
       10. The method according to claim 8 wherein the second agent is phentolamine, phenoxybenzamine, histamine, H 3  agonist, H 1  antagonists, PGE 1  or sulpiride. 
     
     
       11. The method according to claim 8 wherein the H 2  agonist is Impromidine or Dimaprit. 
     
     
       12. The method according to claim 7 wherein the second therapeutic agent is an H 3  agonist, histamine, an α-adrenergic blocker, a dopamine D 2  -antagonist, nitric oxide releaser, prostaglandin or an analog thereof having a vasoactive function, cyclooxygenase inhibitors, calcium antagonists, CGRP, VIP, phentolamine, physiostigmine, neostigmine, hydralazine, sodium, nitroprusside, H 1  antagonist, or phenoxybenzamine. 
     
     
       13. The method according to claim 12 wherein the second therapeutic agent is an H 3  agonists, sulpiride, papaverine, PGE 1 , phentolamine, or histamine. 
     
     
       14. The method according to claim 1 which further comprises administering with the H 2  agonist a penetration enhancing agent. 
     
     
       15. The method according to claim 1 wherein the animal is a human being. 
     
     
       16. The method according to claim 1 which method is applied to animals in the veterinary sciences. 
     
     
       17. The method according to claim 1, 8, or 7 wherein the H 2  agonist is administered by intracavernosum injection. 
     
     
       18. The method according to claim 1, 8, or 7 wherein the H 2  agonist is adminsitered topically. 
     
     
       19. The method according to claim 1, 8, or 7 wherein the H 2  agonist is adminsitered intraurethrally. 
     
     
       20. Unit dose packaging of a single use i.c. injection, a single use topical administration or a single use intraurethral administration wherein said unit dose packaging contains an effective amount of a parenteral, topical or intraurethral dosage of an H 2  agonist that promotes erection. 
     
     
       21. The single dose package, according to claim 20, which further comprises a second therapeutic agent. 
     
     
       22. The unit dose package according to claim 20 wherein the H 2  agonist is Impromidine and is administered intracavernous in an amount from about 25 mcg to about 600 mcg. 
     
     
       23. An intracavernousal composition which composition comprises an effective amount of an H 2  agonist and a pharmaceutically acceptable carrier or diluent. 
     
     
       24. An intraurethral composition, which composition comprises an effective amount of an H 2  agonist and a pharmaceutically acceptable carrier or diluent. 
     
     
       25. The method according to claim 15 wherein the human being is a male. 
     
     
       26. The method according to claim 15 wherein the human being is a female.